The following data is part of a premarket notification filed by Vax-d Medical Technologies Llc with the FDA for Vax-d Genesis G2 System.
| Device ID | K071347 |
| 510k Number | K071347 |
| Device Name: | VAX-D GENESIS G2 SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | VAX-D MEDICAL TECHNOLOGIES LLC 310 MEARS BLVD Oldsmar, FL 34677 |
| Contact | Lawrence Dyer |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-05-14 |
| Decision Date | 2007-10-05 |
| Summary: | summary |